Large Volume Parenterals (LVP) is one of the most competitive pharmaceutical markets. In the production of LVP, quality and cost are two of the main factors that you always have an eye on. Together with GF, ACIC brings an excellent alternative to IV bags. From polypropylene granules melted and injected into pre-forms, all the way down to IV bottle/bag sealing, we have the most cost effective and high quality turn-key solutions.

Some of the main advantages of ISBM systems are the low tool cost, flexibility over a wide range of filling volumes (100 mL – 1000 mL) and shapes, high production rate, high efficiency, zero material waste, lower energy consumption, simple operation, quick change over, and easy maintenance.

Our experience in ISBM includes:

Bottles ISBM
ISBM
  • Injection mold machines for pre-forms
  • Stretch, Blow, Molding machines
  • Hanger welding

ISBM Series: Injection-Stretch-Blow-Molding Machines for Polypropylene (PP) Containers

The ISBM technology is the modern manufacturing trend for Large Volume Parenterals (LVP), both for irrigation and infusion, either in round or shaped Polypropylene (PP) containers (IV plastic bottles and bags).

The polymer granules are first molded into a so-called “pre-form” using an injection molding process; the pre-form includes the neck of the future container, complete with the desired finish and ready for the closure application (welded caps, screw caps, stoppers, and aluminum seals).

The pre-forms are then stretched and blown to the final shape of the container, ready to be transferred to the air blowing, filling, and capping mono-bloc machines, which can be designed also to process oxygen sensitive liquids.

  • Low cost for molding tools and dies
  • Optimized design and structure to allow easy cleaning for all working surfaces due to the absence of dead zones and corners
  • Cost savings due to zero material waste
  • Lower energy consumption
  • Reduced start-up time
  • Possibility of processing recycled packaging components
  • High levels of container transparency for optimized optical inspection
  • Simple orientation, quick change-overs, and low maintenance
  • All product contacting parts are made of AISI 316L stainless steel with finishing ranging from 0.4 – 0.8 RA, or with FDA approved materials
  • Flexibility over a wide range of filling volumes and container shapes, from 50 – 1,000 ml
  • Possibility to adapt different dosing systems such as mass flow meters and time-pressure dosing
  • High production rates and line efficiency
  • Compliant with 21 CFR part 11 FDA guideline
  • User friendly touch screen operator interface (HMI)
  • Customized layout in accordance to special end-user demands
  • Automatic extraction of pre-forms from the injection molding equipment
  • Automatic bulk transport and feeding of pre-forms
  • Automatic load/unload autoclave trays with robots
  • Container air blowing station by means of sterile or ionized air for particle removal
  • Container feeding from unscrambling units, rotary or bi-flow tables, depending on the process and layout configuration
  • Nitrogen purging before, after, during, and after the filling operation
  • Descaled and passivized filling circuit
  • Closure presence control and automatic rejection systems
  • Rinsing and washing modules
  • Statistical or 100% IPC
  • CIP/SIP functionalities
  • Printer and SCADA interface for production data recording and management
  • Remote assistance
  • Documentation packages for complete system validation
  • Integration with conventional LAF units or RABS

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